Redwood City, Calif.-based Avinger, which makes the Pantheris image-guided atherectomy device for treating peripheral artery disease, said it expects to post sales of $4.7 million for the 3 months ended June 30, which would be a 57% increase over Q2 2015.
“Although we experienced lower-than-expected utilization of Pantheris in the 2nd quarter, we remain enthusiastic about the longer-term outlook for this disruptive technology,” president & CEO Jeff Soinski said in prepared remarks. “With an established and growing installed base, we are now focusing more acutely on market development and physician training.”
“Based on our early commercial experience, we have continued to make improvements to Pantheris, and in particular the robustness of its optical imaging fiber, and have received positive feedback from physicians on the performance of the current device. We are also making progress on new versions of Pantheris which include enhanced cutting capabilities for more difficult to treat lesions and a lower profile device for smaller vessels,” added founder & chairman Dr. John Simpson.
In March, Avinger launched an enhanced version of the Pantheris device after winning FDA clearance. Pantheris won its 1st nod from the agency in October 2015; Avinger said the new version features improved ergonomics, physician controls and manufacturability. The device is designed to use optical coherence tomography to allow physicians to visualize the vessel and obstruction during atherectomy procedures to treat peripheral artery disease. Avinger said today that it now expects sales of between $19 million and $23 million this year, down from prior guidance of $25 million to $30 million.
Investors reacted by sending AVGR share prices down -38.5% to $7.03 apiece today in early afternoon trading.
Avinger floated a $65 million initial public offering in January 2015. Last September the company pulled in a $55 million term loan. In March the company registered for the sale of $50 million worth of its own stock.
Late last month Avinger said it’s collaborating with health insurers Highmark Health and Allegheny Health Network to launch a trial of Pantheris to evaluate the device in terms of benefits to patients, providers and payers through the “holistic” evaluation of patient care.